Effective Date: October 2013
Note: In addition to their general data sharing policy, many of the NIH's 27 institutes have specific policies.
- Investigators submitting a research application requesting $500,000 or more of direct costs in any single year to NIH on or after October 1, 2003 are expected to include a plan for sharing final research data for research purposes, or state why data sharing is not possible. Data sharing should occur in a timely fashion. NIH expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset.
- Data Sharing Plan (to follow immediately after the Research Plan Section): The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement.
In an effort to advance rigorous and reproducible research and promote public trust in research, the NIH is implementing a revision to the 2013 Data Sharing Policy.
- Requires submission of Data Management and Sharing Plan for all NIH-funded research (how/where/when) (Learn More)
- What: Scientific data - "Recorded factual material ... of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications." Does not include things materials like lab notebooks, preliminary analyses, case report forms, physical specimens.
- When: Data must be shared no later than publication or end of award (for data underlying findings not published in peer-reviewed journals).
- Compliance with the ICO-approved Plan (may affect future funding)
- Replaces 2003 Data Sharing Policy
To support the highest quality science, public accountability, and social responsibility in the conduct of science, NIH’s Rigor and Transparency efforts are intended to clarify expectations and highlight attention to four areas that may need more explicit attention by applicants and reviewers:
- Scientific premise
- Scientific rigor
- Consideration of relevant biological variables, such as sex
- Authentication of key biological and/or chemical resources
